Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
59305–59328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2007
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK...
K070819 · LCP
Bio-Rad Laboratories Inc., Clinical...
Chemistry · 91d
Cleared Jun 22, 2007
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
K063388 · OBO
Topcon Corp.
Ophthalmic · 226d
Cleared Jun 22, 2007
SILICONE TISSUE EXPANDER
K070303 · LCJ
Specialty Surgical Products
General & Plastic Surgery · 142d
Cleared Jun 22, 2007
ENZYMATIC CREATININE ASSAY (265 SERIES)
K070383 · JFY
Diagnostic Chemicals , Ltd.
Chemistry · 133d
Cleared Jun 22, 2007
MICRODOT BLOOD GLUCOSE MONITORING SYSTEM
K070524 · NBW
Cambridge Sensors Limited
Chemistry · 119d
Cleared Jun 22, 2007
TRIFLEX SELECT
K070647 · KGO
Cardinal Health, Inc.
General Hospital · 106d
Cleared Jun 22, 2007
MAMMAPRINT
K070675 · NYI
Agendia BV
Pathology · 102d
Cleared Jun 22, 2007
ATLANTIS ABUTMENT FOR ASTRA IMPLANT
K070833 · NHA
Atlantis Components, Inc.
Dental · 87d
Cleared Jun 22, 2007
ARX-LINK CROSS CONNECTOR
K070995 · NKB
Life Spine
Orthopedic · 74d
Cleared Jun 22, 2007
ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
K071025 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 72d
Cleared Jun 22, 2007
ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
K071064 · HSD
Ascension Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 22, 2007
OTOMEDICS SOFT TYMPANOSTOMY TUBE
K071178 · ETD
Otomedics Advanced Medical...
Ear, Nose, Throat · 56d
Cleared Jun 22, 2007
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS...
K071184 · HRS
Synthes (Usa)
Orthopedic · 53d
Cleared Jun 22, 2007
BLUGOO HD
K071192 · ELW
Lancer Orthodontics, Inc.
Dental · 53d
Cleared Jun 22, 2007
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
K071297 · LLZ
Agfa Healthcare Corp.
Radiology · 44d
Cleared Jun 22, 2007
POWDERED LATEX EXAMINATION GLOVES
K071323 · LYY
Quality Gallant Sdn. Bhd.
General Hospital · 43d
Cleared Jun 22, 2007
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
K071401 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 32d
Cleared Jun 21, 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
K062372 · DFH
The Binding Site, Ltd.
Immunology · 311d
Cleared Jun 21, 2007
ST AIA-PACK INTACT PTH ASSAY
K063605 · CEW
Tosoh Bioscience, Inc.
Chemistry · 199d
Cleared Jun 21, 2007
PRELUDE SHEATH INTRODUCER
K070159 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 155d
Cleared Jun 21, 2007
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
K070491 · FLL
K-Jump Health Co., Ltd.
General Hospital · 121d
Cleared Jun 21, 2007
BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS
K070533 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 115d
Cleared Jun 21, 2007
TOPICAL APPLICATOR
K070596 · CCT
Sharn, Inc.
Anesthesiology · 111d
Cleared Jun 21, 2007
SKATER BILIARY CATHETER
K070610 · FGE
Angiotech
Gastroenterology & Urology · 108d